QA Compliance Specialist

4 days ago

Cairo, Egypt Multicare Egypt for Pharmaceutical Industries Full time

Multicare Egypt for Pharmaceutical Industries is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, gender identity or expression, age disability, or other characteristics protected by prevailing regulations, practice or customs/traditions.

Multicare is a well-established Pharmaceutical Company with diversified scope in both manufacturing and marketing of pharmaceutical products, supplements, cosmetics and medical devices. Multicare has +21 years of prominent existence in the local market and has almost +66 products marketed and more to come through the pipelines. Multicare Egypt for Pharmaceutical Industries is the manufacturing facility located at the Industrial Zone - New Cairo and its HQ at New Cairo as well. We are one of the fast growing Pharmaceutical Companies in the market which has strong ambition and aspiration to be one of the key players not only in Egypt but also within the region.
Our international alliances are effective in different countries, including Saudi Arabia, United Arab of Emirates, India and New Zealand with future aspiration to extend more business associations and affiliations in near future to further markets. Recently Multicare Poland has been launched which will be the entry port of the business to the European Union (EU).

**Vacancy**:
Designation: QA Validation Specialist
Location: New Cairo HQ
Job Grade: qAv1/qAv02
Reporting: QA Section Head

**Job Purpose**:
This position is responsible for assisting with Quality Assurance tasks and managing company documents while also ensuring their accuracy, quality and integrity. Adheres to record retention policies, safeguard information and retrieve data more effectively

**A.Essential Duties and Responsibilities**:

- Coordinate and performs batch record disposition of development, finished products and raw materials
- Review and approve manufacturing and QC related documents for batch record disposition
- Initiate, Review and approve deviations, CAPAs, change controls, facility Work Orders, and any other site/product related documents ensuring adequate levels of documentation are adequate and compliant to existing procedures
- Ensure the Disposition process meets industry and Multicare expectations and requirements
- Drive continuous improvement and enhancement efforts to the Disposition process to ensure an efficient yet Compliant process is maintained
- Support on quality manual implementation teams in area of technical expertise as required
- Support regulatory agency inspections, by way of auditing, training and preparation, and tracking commitments
- Work with site personnel to ensure completion of all regulatory commitments.
- Support maintenance of central file for correctives and inspection history
- Coordinate / Support Change Controls as needed
- Write, review and approve Policies, Standard Operating Procedures (SOPs) and associated processes/guidelines
- Coordinate activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings to lead/facilitate investigations and to provide updates on discrepancy investigations; publish notes and action items from meetings; provide support to the investigation process and follow-up to assure timely discrepancy closure
- Perform independent quality evaluation of deviation reports including root cause analysis cause/preventive action identification, CAPA effectiveness check and trending
- Participate in the internal audit program
- Revise and issuing the SOP's for all the departments
- Ensure strict adherence to Multicare standard operating procedures & GMP principles
- Ensure GMP compliant start-up
- Act as a backup person for the QA inspectors by checking in-process testing done by production technicians by performing tests, reviewing test data, filling in the manufacturing& packaging batch records and writing investigations according to SOPs and GMPs.
- Check in-process testing done by production technicians by performing testing, reviewing test data, and writing investigations according to SOPs and GMPs

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